Preliminary findings from stimulated spontaneous reporting of adverse drug reactions during COVID-19 pandemic: an experience from Ghana

Abstract

Background: The novel coronavirus disease 2019 (COVID-19) is an ongoing pandemic caused by severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2). There is limited information on the safety of drugs used for the treatment of COVID-19.Objective: Objective of this study is to describe the pattern of stimulated spontaneous adverse drug reaction (ADR) reports received from healthcare professionals for SARS-CoV-2 positive patients in Ghana and lessons learnt particularly for low- and middle-income countries.Methods: This is a study of individual case safety reports (ICSRs) received from healthcare professionals between 1st April 2020 to 31st July 2020 in SARS-CoV-2 positive patients in Ghana. The ICSRs were retrieved from the SafetyWatch System and descriptive statistics used to describe the ADRs by System Organ Classification and Preferred Term.Results: Information was received from 40 COVID-19 Treatment Centres across the country with 9 centres submitting a total of 53 ICSRs containing 101 ADRs; approximately two ADRs per ICSR. Females accounted for 29(54.7%) of the ICSRs and males 24(45.3%). Newly reported ADRs of interest were one report each of tremor for doxycycline; scrotal pain, dyspnoea, gait disturbances and dysgeusia for chloroquine; and dry throat, hyperhidrosis, restlessness and micturition frequency increased for hydroxychloroquine. A strong spontaneous system with the availability of focal persons at the Treatment Centres played a key role in reporting ADRs during the pandemic.Conclusion: This is the first experience with spontaneous reporting during COVID-19 pandemic in Ghana. The profile of most of the ADRs reported appears consistent with what is expected from the summary of product characteristics. A study with a larger sample size with well-defined denominator in future studies is paramount in determining the relative risk of these medications in SARS-CoV-2 positive patients.

Eventos adversos no sistema nervoso central potencialmente relacionados aos medicamentos utilizados na COVID-19: revisão de escopo

“…No estudo observacional de Darko et al ( 11 ), foram analisadas as notificações de eventos adversos a medicamentos realizadas por 40 centros de tratamento de COVID-19 em Gana, na África. Foram realizadas 53 notificações que reportaram 101 potenciais eventos adversos a medicamentos (sete suspeitas de inefetividade terapêutica ou circunstância de risco, ou seja, erro de medicação; 85 RAM esperadas, ou seja, descritas em bula; e nove RAM inesperadas) (8,9%).…”

“…Quatro estudos avaliaram a causalidade das RAM, mas apenas dois reportaram o instrumento utilizado ( 11 , 15 ). Todos foram do tipo observacional, e a imputação causal dos eventos adversos potenciais no SNC foi possível.…”

Landscape review of active vaccine safety surveillance activities for COVID-19 vaccines globally

“…Improvements were largely noted in the collection of AEFI reports and within data management systems. Increased public awareness and stimulated reporting increased AEFI reporting into passive reporting systems [20] , and a tool to facilitate capture of AEFI reports from NIP in the WHO global database was implemented [21] . National regulatory authorities engaged in new regional collaborations for work-sharing and signal management, most notably in Africa’s African Union Smart Safety Surveillance (AU-3S) [22] .…”

Covid-19 Pandemic and Medicines Regulation in Ghana: Overview and Perspectives of Regulators

“…Monitoring quality and effectiveness of authorized COVID-19 medicines remains the prerogative of regulators through their regulatory oversight and post-market surveillance 7 . Regulators have enhanced their pharmacovigilance activities to detect and respond to adverse events associated with COVID-19 treatments and vaccines 8 . Additionally, the COVID-19 pandemic has prompted regulatory agencies on the importance of global regulatory collaboration and harmonization.…”